Pfizer and BioNTech plan to submit the data to authorities “as soon as possible,” according to a statement.
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The Pfizer-BioNTech vaccine against Covid-19 is “sure” and “well tolerated” by children aged 5 to 11, according to the results of a study announced Monday, September 20 by the two laboratories. Companies add that the right dosage triggers an immune response “robust” and “comparable” to that observed in 16 to 25 year olds who received a higher dose vaccine. Pfizer and BioNTech plan to submit this data to authorities “as soon as possible”, according to a statement.
These are the first clinical data for this age group. The European Medicines Agency (EMA) and the US FDA have authorized messenger RNA vaccines from the age of 12. Due in particular to the diffusion of the Delta variant, “Since July, pediatric cases of Covid-19 have increased by 240% in the United States, highlighting the need for vaccination” of the youngest, commented Albert Bourla, CEO of Pfizer. He considered that these data constitute a “solid basis for authorization requests”.
The side effects of the vaccine, dosed at 10 micrograms by injection compared to 30 micrograms usually for the elderly, are “generally comparable” to those observed in people aged 16 to 25, note the two laboratories. These are partial results of a study carried out on 4,500 children between 6 months and 11 years old in the United States, Finland, Poland and Spain. Both companies expect to publish “from the fourth quarter” results concerning the age group 2-5 years as well as 6 months-2 years, who received two injections of 3 micrograms. The study on children under 12 for the Moderna vaccine is ongoing.